eq-8k_20191001.htm

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

September 30, 2019

Date of Report (Date of earliest event reported)

 

Equillium, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

001-38692

 

82-1554746

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

 

2223 Avenida de la Playa, Suite 105

La Jolla, CA

 

92037

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (858) 412-5302  

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each Class 

Trading Symbol

Name of Each Exchange on Which Registered 

Common Stock, par value $0.0001 per share

EQ

The Nasdaq Global Market

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) 

  

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b2 of the Securities Exchange Act of 1934 (§ 240.12b2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 


 

Item 1.01.

Entry into a Material Definitive Agreement.

On September 30, 2019 (the “Effective Date”), Equillium, Inc. (the “Company”) entered into a loan and security agreement (the “Agreement”) with Oxford Finance LLC (“Oxford”), as the collateral agent and a lender, and Silicon Valley Bank, as a lender (together with Oxford, the “Lenders”), pursuant to which the Lenders have agreed to lend the Company up to $20.0 million in a series of term loans. Upon entering into the Agreement, the Company borrowed $10.0 million from the Lenders (“Term A Loan”).

Under the terms of the Agreement, the Company may, at its sole discretion, borrow from the Lenders (i) up to an additional $5.0 million (“Term B Loan”) upon the Company’s achievement of positive topline data in either the Company’s (a) EQ001 Phase 1b aGvHD trial or (b) EQ001 Phase 1b asthma trial, supporting a formal decision to advance into Phase 2 development, and as confirmed by the Company’s Board of Directors (the “Term B Milestone”) and (ii) up to an additional $5.0 million (“Term C Loan” and together with Term A Loan and Term B Loan, the “Term Loans”) upon the Company’s achievement of positive topline data in both the Company’s EQ001 Phase 1b aGvHD trial and the Company’s EQ001 Phase 1b asthma trial, supporting a formal decision to advance into Phase 2 development, and as confirmed by the Company’s Board of Directors (the “Term C Milestone”).  The Company may draw the Term B Loan during the period commencing on the date of the occurrence of the Term B Milestone and ending on the earliest of (i) December 31, 2020, (ii) 60 days after achieving the Term B Milestone, and (iii) the occurrence of an event of default and may draw the Term C Loan during the period commencing on the date of the occurrence of the Term C Milestone and ending on the earliest of (i) December 31, 2020, (ii) 60 days after achieving the Term C Milestone, and (iii) the occurrence of an event of default.

The proceeds from the Term Loans under the Agreement may be used to satisfy the Company’s future working capital needs and to fund its general business requirements. The Company’s obligations under the Agreement are secured by a first priority perfected security interest in substantially all of the Company’s current and future assets, other than its intellectual property (except rights to payment from the sale, licensing or disposition of such intellectual property).  The Company has also agreed not to encumber its intellectual property assets, except as permitted by the Agreement.

All of the Term Loans mature on June 1, 2024 (the “Maturity Date”) and will be interest-only through June 30, 2021, followed by 36 equal monthly payments of principal and interest; provided that if the Company draws the Term B Loan, the Term Loans will be interest-only through December 31, 2021, followed by 30 equal monthly payments of principal and interest. The Term Loans will bear interest at a floating per annum rate equal to the greater of (i) 8.25% and (ii) the sum of (a) the prime rate reported in The Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue, plus (b) 3.00%.  

The Company will be required to make a final payment of 4.50% of the original principal amount of the Term Loans drawn payable on the earlier of (i) the Maturity Date, (ii) the acceleration of any Term Loans, or (iii) the prepayment of the Term Loans (the “Final Payment”). The Company may prepay all, but not less than all, of the Term Loans upon 30 days’ advance written notice to Oxford, provided that the Company will be obligated to pay a prepayment fee equal to (i) 3.00% of the principal amount of the applicable Term Loan prepaid on or before the first anniversary of the applicable funding date, (ii) 2.00% of the principal amount of the applicable Term Loan prepaid between the first and second anniversary of the applicable funding date, and (iii) 1.00% of the principal amount of the applicable Term Loan prepaid thereafter, and prior to the Maturity Date (each, a “Prepayment Fee”).  

 

The Company is subject to a number of affirmative and restrictive covenants pursuant to the Agreement, including covenants regarding delivery of financial statements, maintenance of inventory, payment of taxes, maintenance of insurance, protection of intellectual property rights, dispositions of property, business combinations or acquisitions, incurrence of additional indebtedness or liens, investments and transactions with affiliates, among other customary covenants. The Company is also restricted from paying dividends or making other distributions or payments on its capital stock, subject to limited exceptions.

 


 

Upon the occurrence of certain events, including but not limited to the Company’s failure to satisfy its payment obligations under the Agreement, the breach of certain of its other covenants under the Agreement, or the occurrence of a material adverse change, cross defaults to other indebtedness or material agreements, judgment defaults and defaults related to failure to maintain governmental approvals failure of which to maintain could result in a material adverse effect, Oxford will have the right, among other remedies, to declare all principal and interest immediately due and payable, to exercise secured party remedies, to receive the Final Payment and, if the payment of principal and interest is due prior to the Maturity Date, to receive the applicable Prepayment Fee.

 

In connection with entering into the Agreement, the Company issued to the Lenders warrants exercisable for 80,428 shares of the Company’s common stock (the “Warrants”). The Warrants are exercisable in whole or in part, immediately, and have a per share exercise price of $3.73, which is the closing price of the Company’s common stock reported on the Nasdaq Global Market on the day prior to the Effective Date. The Warrants will terminate on the earlier of September 30, 2029  or the closing of a certain merger or consolidation transactions. If the Company borrows under Term B Loan and/or Term C Loan, upon the funding of Term B Loan and/or Term C Loan, as applicable, the Company will issue to the Lenders additional warrants to purchase shares of the Company’s common stock equal to 3.00% of each Term Loan amount divided by the lower of (i) the ten day average closing price of the Company’s common stock reported on the Nasdaq Global Market prior to funding or (ii) the closing price of the Company’s common stock reported on the Nasdaq Global Market on the day prior to funding.  Such lower amount of (i) and (ii) above shall also be the exercise price per share for such warrants. The terms of such warrants would be substantially the same as those contained in the Warrants.

The foregoing is only a summary of the material terms of the Agreement and the Warrants, and does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement and the Warrants, which will be filed as exhibits to the Company’s Quarterly Report on Form 10-Q for the quarterly period ending September 30, 2019.

 

Item 2.03.

Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.

The information set forth under Item 1.01 above is hereby incorporated by reference into Item 2.03.

 

Item 3.02.

Unregistered Sales of Equity Securities.

The information set forth under Item 1.01 above that relates to the issuance of the Warrants is hereby incorporated by reference into Item 3.02.

The Warrants described in Item 1.01 above were offered and sold in reliance upon the exemption from registration provided by Section 4(a)(2) under the Securities Act of 1933, as amended (the “Securities Act”), in that the issuance of the Warrants did not involve a public offering.

 

Item 7.01

Regulation FD Disclosure.

On October 1, 2019, the Company updated its corporate slide presentation for use in meetings with investors, analysts and others. The presentation is available through the Company’s website and a copy is attached as Exhibit 99.1 hereto.

The information in this Item 7.01, including Exhibit 99.1, is being furnished pursuant to Item 7.01 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and it shall not be deemed incorporated by reference in any filing under the Securities Act or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this item of this report.

 

 


 

Item 8.01.

Other Events.

 

On October 1, 2019, the Company issued a press release announcing the entry into the Agreement described under Item 1.01 above and certain business updates regarding the Company. A copy of this press release is attached hereto as Exhibit 99.2 and incorporated herein by reference.

 

Item 9.01.

Financial Statements and Exhibits.

(d)  Exhibits

 

Exhibit
Number

  

Description

 

 

99.1

  

Slide Presentation dated October 1, 2019.

99.2

  

Press Release dated October 1, 2019.

 


 


 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

 

Equillium, Inc.

 

 

 

 

 

 

Dated: October 1, 2019

 

 

By:

 

/s/ Jason A. Keyes

 

 

 

 

 

Jason A. Keyes

 

 

 

 

 

Chief Financial Officer

 

 

eq-ex991_15.htm

Exhibit 99.1

 

 

Company Logo harnessing novel immunobiology October 2019 www. Equilliumbio.com


 

 

Safe Harbor Statement This presentation contains forward-looking statements about Equillium, Inc. (the “Company”). In some cases, you can identify forward-looking statements by the words “will,” “expect,” “intend,” “plan,” “objective,” “believe,” “estimate,” “potential,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements are based on Company management’s current beliefs and expectations. These statements include but are not limited to statements regarding the Company’s business strategy, the Company’s plans to develop and commercialize its product candidates, the safety and efficacy of the Company’s product candidates, the Company’s plans and expected timing with respect to regulatory filings and approvals, size and growth potential of the markets for the Company’s product candidates and cash runway.  These statements involve substantial known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements.The Company may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on the Company’s forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed or implied in the forward-looking statements the Company makes due to the risks and uncertainties inherent in the Company’s business, including without limitation, risk described in the Company’s filings with the Securities and Exchange Commission (“SEC”). You are cautioned not to place undue reliance on these forward-looking statements, which represent the Company’s views as of the date of this presentation. The Company’s anticipates that subsequent events and developments will cause the its views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company has no current intention of doing so except to the extent required by applicable law. These and other risks and uncertainties are described more fully under the caption “Risk Factors” and elsewhere in the Company’s filings and reports, which may be accessed for free by visiting EDGAR on the SEC web site at http://www.sec.gov. and on the Company’s website under the heading “Investors.”  All forward-looking statements are qualified in their entirety by this cautionary statement.  This caution made under the “safe harbor” provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.Company Logo


 

 

Delivering powerful new treatment approaches Focused on immuno-inflammatory diseases with high unmet need Driven by an accomplished team rapidly delivering key milestones Our lead asset, itolizumab, is unique, modulating both the activity and trafficking of Teff cells Initial clinical programs are targeting diseases with limited or no treatment options Three clinical studies initiated 2019


 

 

Accomplished Management Team Dan Bradbury Chairman & Chief Executive Officer Bruce Steel, CFA President & Chief Business Officer Steve Connelly, PhD Chief Scientific Officer Krishna Polu, MD Chief Medical Officer Jason Keyes Chief Financial Officer Christine Zedelmayer Vice-President of Operations amylin gsk glaxosmithkline biomed ventures anaphore Rincon pharmaceuticals ambit biosciences biomed ventures atry pharma the scripps research institute raptor cytomx therapeutics affymax amgen orexigen amylin amgen baxter amylin amgen ligand  Company logo


 

 

Itolizumab (EQ001) First-in-class Lead Program First-in-class anti-CD6 mAb that inhibits the activity and trafficking of Teff cells by selectively targeting the CD6/ALCAM pathway Broad potential ‘pipeline in a product’ –multiple high-value indications applicable, three clinical studies underway Validated therapeutic –studied in over 330 patients and approved for the treatment of psoriasis in India Equillium acquired exclusive rights to itolizumab for the U.S. & Canada from Biocon–partnership provides clinical & commercial product, commercial scale production at FDA regulated facility Company Logo


 

 

Itolizumab Development Strategy Equilliumis well-capitalized and staffed to execute on key programs uncontrolled asthma aGVHD Indication Phase 1 Phase 1b / 2 Phase 3 Expected Milestones FDA Fast Track Orphan Drug Designation Lupus nephritis EQUATE Phase 1b/2 aGVHD trial initiated March 2019 Data to inform further development in GVHD, e.g. GVHD prevention, cGVHD Initial data expected 2H 2020 EQUIP Phase 1b uncontrolled moderate to severe asthma trial initiated June 2019 Initial data expected 2H 2020 EQUALISE Phase 1b trial initiated September 2019 Data to inform further development in lupus Initial data in patients with active or inactive SLE without lupus nephritis expected 2H 2020; initial data in patients with lupus nephritis expected 1H 2021 Company logo


 

 

The cd6/alcam pathway


 

 

CD6/ALCAM Pathway Central to Immuno-inflammation T CELL APC / TISSUE ALCAM CD6 CD6 is a co-stimulatory receptor expressed on T cells, differentially expressed on subsets of innate lymphoid (ILC) and natural killer (NK) cells, but not on T regulatory cells (Treg) Activated leukocyte cell adhesion molecule (ALCAM), is expressed on both antigen-presenting cells and endothelial/epithelial tissue including the blood-brain-barrier, skin, gut, lung and kidney The binding of CD6/ALCAM is important for: Immune synapse formation Optimal co-stimulation and activation Trafficking into tissues The CD6/ALCAM pathway modulates T cell activity and trafficking and is central to the pathogenesis of multiple immuno-inflammatory diseases Company Logo


 

 

ALCAM EQ001 CD6 Itolizumab Humanized IgG1 Kappa Binds to domain 1 of human CD6 with 1.3 nM affinity Inhibits ALCAM binding to CD6 Non-depleting, modulatory action Manufacturing and formulation Manufactured in CHO cells at commercial scale IV and SC formulations available Dosing Half-life IV/SC @ 20/24 days respectively; target dosing of bi-weekly to monthly with potential for quarterly maintenance T CELL APC / TISSUE Itolizumab Modulates CD6/ALCAM Pathway Company Logo


 

 

CD6 –Central Role in T Effector Cell Development Highest levels of CD6 are found on activated T effector cells (Teff) and associated with amplification of the auto-reactive cascade CD6 Low/- CD6+ CD6Hi Treg Weak Signalling Tnaive Strong Signalling Teff Th1 Th2 Th17 CD6 Immune Regulatory “Tolerance” Autoreactive “Autoimmunity” Chart Company Logo


 

 

CD6/ALCAM Pathway Central to Immuno-inflammation ACTIVITY TRAFFICKING Increased proinflammatory cytokine secretion Optimal immune synapse formation, activation and proliferation Increased trafficking of Teff cells into target tissues Suppression of regulatory pathways Company Logo Chart


 

 

Itolizumab Inhibits Pathogenic T Cell Activity & Trafficking ACTIVITY TRAFFICKING Decreased proinflammatory cytokine secretion Inhibits optimal synapse formation co-stimulation, activation and proliferation Decreased trafficking of Teff cells into target tissues Restoration of regulatory pathways Chart Company Logo


 

 

Upstream, Disease Modifying Immuno-inflammatory Mechanism Itolizumab acts upstream and selectively targets autoreactive effector T cells, while sparing regulatory T cells to promote immune tolerance and durable disease remission Synergistic inhibition of multiple Teff cells and cytokines* Inhibition of Teff trafficking into key target organs Restoration of immune regulation without immunosuppression T eff T eff T eff T eff T eff Th1 / Th2 / Th17 Teff Treg T eff *including but not limited to IFN-γ, TNF-α, IL-4, IL-5, IL-6, IL-13 and IL-17  Chart Company Logo


 

 

Clinical Strategy


 

 

Uncontrolled moderate to severe asthma A heterogeneous disease characterized by different Teff cell subtypes and other innate immune cells driving both allergic and autoimmune mechanisms, leading to chronic airway inflammation 2.6mm Severe asthma patients in the U.S. 1.3mm Patients uncontrolled by standard-of-care treatments (long-acting beta-agonists, inhaled corticosteroids, oral corticosteroids) ~50% Of uncontrolled patients do not respond to existing biologic treatments 0 Approved products covering the full spectrum of disease (Th2 High to Non-Th2 asthma) 2 Products in development that target Non-Th2 asthma 1 Product in development that modulates both the activity and trafficking of Teff cells – itolizumab All numbers are approximate and based on published reports


 

 

CD6-ALCAM Implicated Broadly in the Pathogenesis of Asthma Type 2 Inflammation Non-Type 2 / Th17 Inflammation Allergens Irritants, pollutants, microbes, and viruses TSLP IL-25 IL-33 IL-13 IL-4, IL-5, IL-13 IL-6 TGF-ΒV IL-23 CXCL8 GM-CSF IL-4 IL-5 IL-6, IL-17, IL-8 IFN-Y TNF IL-3, IL-4, IL-5, IL-9 B cell IGE Mast cell Eosinophil ALCAM Neutrophil Th1 cell Th17 cell ILC2 Th2cell Teff CD6 CD6 CD6 Asthma Figure Legend:CD6 is expressed on Th1, Th2, Th17 and ILC2 effector cells that secrete multiple proinflammatory cytokines implicated in asthma pathogenesis. ALCAM is expressed on antigen presentation cells that activate effector cells.  ALCAM is also expressed on endothelial and smooth muscle cells where it plays a role in trafficking of CD6+ effector cells.  Adapted from Israel E, et al., N Engl J Med. 2017;377(10):965-976.Chart Company Logo


 

 

Itolizumab May Address the Full Spectrum of Uncontrolled Asthma Th2-High Eosinophils Th2-Low Low Eosinophils Non-Th2 Neutrophils Reciprocally regulated Th2 Th2 Th17 Th17 Response to steroids Current therapies target downstream signaling of Th2-associated inflammation Current downstream therapies ineffective in patients with low levels of eosinophils No approved therapies Anti-ige anti-IL-5 anti-IL-4 and IL-13 DP2 Agonist anti-CD6/ALCAM anti-TSLP CHART Company Logo


 

 

Itolizumab Targets both Th2 and Non-Th2 Asthma Pathogenesis Modulating CD6-ALCAM pathway attenuates activity and trafficking of Th1 (IFN-y), Th2 (IL-4,5,13), Th17 (IL-17) cells and cytokines in multiple models of autoimmune and allergic inflammation Transcriptional and histological analyses support the presence of increased CD6, CD4 T cells, and ALCAM in the lungs of severe asthma patients Asthma is a heterogenous disease with CD6+ Th1 (IFN-y), Th2 (IL-4,5,13), Th17 (IL-17) and ILC cells and cytokines involved in the pathogenesis Th17 and ILC cells are steroid resistant ALCAM expressed on lung tissues facilitates infiltration of CD6+ Teff cells High Th17:Treg ratio associated with asthma exacerbations  Uncontrolled moderate to severe asthma proof-of-concept trial to initiate Q2 2019 Data to inform further development in Th2 and non-Th2 asthma Translational Validation Clinical Development Scientific Rationale Kim et al., 2028. “Activated leukocyte cell adhesion molecule stimulates the t-cell response in allergic asthma.” American Journal of Respiratory and Critical Care Medicine. 197(8); Li et al, 2017. “CD6 as a potential target for treating multiple sclerosis.” PNAS 114(10): 2687-2692; Bughani et al., 2018. “T cell activation and differentiation is modulated by a CD6 domain 1 antibody itolizumab.” PLoS One 12(7): e0180088 Company Logo


 

 

Upregulation of CD6 & ALCAM in Severe Asthma Patients Examination of gene expression datasets and lung tissue support the presence of increased CD6, CD4 T cells, and ALCAM in the lungs of severe asthma patients Analysis of two different gene expression datasets support the presence of increased CD6, CD4 T cells, and ALCAM in the lungs of severe asthma patients Fatal asthma patients lung tissue staining suggests increased numbers of CD6+ cells, upregulation of ALCAM in the lamina propria (mucosa), and co-localization of CD6+ cells with ALCAM expressing tissue Study of the Mechanisms of Asthma (MAST; NCT00595153); Bronchoscopic Exploratory Research Study of Biomarkers in Corticosteroid-refractory Asthma (BOBCAT) study; Data courtesy of Reynold A. Panettieri, Jr., MD, Rutgers Institute for Translational Medicine and Science CHART Company Logo


 

 

EQUIP Study in Uncontrolled Asthma EQUIP Study Population: Uncontrolled moderate to severe asthma patients Study Design Primary Objectives Secondary Objectives Phase 1b N=32 Randomized, double-blind, placebo controlled, dose escalation study Assess the safety and tolerability of subcutaneous dosing of itolizumab Determine optimal subcutaneous dose level(s) of itolizumab Characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of itolizumab Assess the clinical activity of itolizumab (FEV1, ACQ, FeNO, Eos) Phase 1b initial dataexpected 2H 2020 Chart Company Logo


 

 

Acute graft-versus-host disease (aGVHD) A multisystem complication of allogeneic hematopoietic stem cell transplants, or allo-HSCT, caused by Teff cells, recognizing and attacking the recipient’s body 8,500 Allo-HSCT’s performed in 2016 4% procedural growth year-over-year 30-70% Allo-HSCT patients will develop aGVHD 53% Survival rate for steroid responders 95% Mortality rate for steroid non-responders 0 Number of approved treatments for first-line aGVHD 1 Product in development thar modulates both the activity and trafficking of Teff cells – itolizumab All numbers are approximate and based on published reports


 

 

aGVHD CD 6+ T Cells Drive GVHD Bar Chart Irradiation leads to activation of donor T cells T cell Proliferation and secretion of proinflammatory cytokine Activated donor T cells infiltrate tissues (Graphic) GUT SKIN LIVER Company Logo


 

 

aGVHD Itolizumab is a Differentiated aGVHD Treatment Option Acute GVHD Company Logo Itolizumab 0-100 days post-transplant First line positioning Dual mode of action inhibits the activity and trafficking of Teff cells Potential disease-modifying therapy with durable benefit Immunomodulatory vs. immunosuppressive no cytopenia seen in Biocon Phase 3 psoriasis studies Positive Phase 1b data will inform lifecycle opportunity in GVHD prevention and cGVHD Prevention First-line Steroid-refractory Graphic Company Logo


 

 

aGVHD Strong Scientific Rationale for Itolizumab in aGVHD Scientific Rationale th 17 cells expressing CD6 play a critical role in the pathogenesis of aGVHD th17 cells are steroid resistant ALCAM expressed on target organs facilitates infiltration of CD6+ Teff cells Studies have shown a high th17:Treg ratio indicative of a loss of tolerance in aGVHD patients Translational Validation Itolizumab shown to be effective in animal models of GVHD and inflammatory bowel disease (IBD) Ex vivo depletion of CD6+ Teff cells from donor bone marrow prior to allogeneic transplant effectively reduced GVHD incidence CD6+T cells drive th 1/th 17 immune responses and mucosal inflammation in IBD Clinical Development FDA Fast Track for treatment of aGVHD and Orphan Drug Designations for both the prevention and treatment of aGVHD Phase 1b/2 aGVHD trial initiated in Q1 2019 Data to inform further development in GVHD, e.g. GVHD prevention, cGVHD Soiffer et all., 1992 ‘‘Prevention of graft-vs-host disease by selective depletion of CD6-positive T lymphocytes from donor bone marrow.” J Clin Oncol 10(7): 1191-1200; Ma et al., 2018. ‘‘Critical role of CD6high CD4+ T cells in driving Th1/Th17 cells immune responses and mucosal inflammation in IBD.” J Crohn’s and Cotitis 13 (4): 510-520 Company Logo


 

 

aGVHD EQUATE Study for First-line Treatment in aGVHD EQUATE Study Population: First-line treatment of newly diagnosed aGVHD patients Study Design Phase 1b N~24 (high-risk Macmillan criteria Open-label,3x3, dose escalation Primary Objectives Assess the safety and tolerability of intravenous (IV) dosing of itolizumab Determine optimal IV dose level (S) of itolizumab Secondary Objectives Characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of itolizumab Assess the clinical activity of itolizumab GVHD ORR,NRM, CGVHD, durability Phase 2 N~ 60 (Grade II – IV) Randomized, double-blind, placebo controlled Assess the clinical activity of itolizumab (GVHD ORR,NRM,CGVHD, durability Further characterize the safety, tolerability and PD of intravenous (IV) dosing of itolizumab Phase 1b initial date expected 2h 2020 Phase 1b informs Phase 2 study as well as lifecycle strategy that may include GVHD prevention and cGVHD Company Logo


 

 

Lupus nephritis a heterogeneous disease that is the most frequent and serious manifestation of system lupus erythematosus (SLE) 100,000 Lupus nephritis patients in the U.S. 50%-75% Of patients do not respond to frontline treatments 40% Of severe, proliferative patients will progress to end-stage renal disease 0 Approved treatments 9 Products in development 1 Product in development that modulates both the activity and trafficking of Teff cells -itolizumab All numbers are approximate and based on published reports


 

 

T Cell Directed Therapies Represent a Promising Approach Activated APC’s/dendritic cells T cells play a central role in the immunopathogenesis of lupus, with aberrant T cell activation and function leading to defective peripheral tolerance Effector cytokines T cells also secrete pro-inflammatory cytokines, help B cells generate autoantibodies, and maintain disease through accumulation of autoreactive memory T cells B cell directed and single cytokine approaches have previously failed in lupus nephritis in Phase 3 trials Current T cell approaches have demonstrated promising efficacy (MMF, Cytoxan), but have significant toxicities and a narrow therapeutic index Activated effector cells Tcell Bcell Targeted Cytokine Complement Inhibition (Bar Chart) Activated B cells B cell Tissue-targeting Antibodies Complement-mediated destruction Company Logo


 

 

Itolizumab Targets Lupus Nephritis Pathogenesis Scientific Rationale Teffcells play a central role in the pathogenesis of lupus Multiple Teffcells/cytokines, such Th1/IFN-γ, Th2/IL-4 and Th17/IL-17 have been implicated Elevated Th17cells are accompanied by a decrease of Tregcells, promoting loss of tolerance Translational Validation Supportive preclinical models in lupus and lupus nephritis Kidney biopsy analysis reveal upregulation of CD6 and ALCAM expression on infiltrating T cells, innate immune cells, and resident renal cells Elevation in urinary ALCAM identifies patients with active lupus nephritis Clinical Development Lupus nephritis proof-of-concept trial to initiate H2 2019 Urinary biomarker strategy to inform patient selection strategy Data to inform further lifecycle strategy in lupus(e.g. SLE and cutaneous lupus) (Company Logo) Stanley et al.,2016.Comprehensive Aptamer-Based Screening of 1129 Proteins Reveals Novel Urinary Biomarkers of Lupus Nephritis. ACR/ARHP Annual Meeting. Company logo


 

 

Treating Lupus Nephritis Today – Similar Treatment for All Patients (Graphic) Standard diagnostics unable to inform biological differences between patients All patients treated uniformly with limited choices Patients may be exposed to ineffective therapies Payers pay for treatments that are ineffective in some patients and also pay for the associated complications Company Logo


 

 

Treating Lupus Nephritis Tomorrow –Individualized Therapy (Graphic) Biomarker driven diagnostics inform differences between patients and guide treatment Therapy benefit -to-risk improved for patients who may respond Use of ineffective treatments minimized –lower overall cost to health care system Company Logo


 

 

ALCAM is a Predictive Biomarker in Patients with Active Lupus Nephritis Unbiased screening of >1100 urinary proteins identified urinary ALCAM as a strong predictor of disease activity in lupus nephritis patients Urinary Biomarker Outperforms Standard Disease Biomarkers in Lupus Nephritis* Urinary ALCAM Elevated in Active Lupus Nephritis Distribution of ALCAM levels seen within race and disease severity* Performance of urinary protein markers in differentiating active lupus nephritis (N=89) from inactive lupus nephritis (N=60) in African American and Hispanic systemic lupus erythematosus patients -UT Southwestern Medical Center, TX Urinary ALCAM0.91 (0.86 –0.96) < 0.0001 0.91 0.82 0.88 0.86 Positive anti-dsDNA NA 0.38 0.57 0.57 0.38 Low complement NA 0.56 0.55 0.65 0.46Stanley et al.,2016.Comprehensive Aptamer-Based Screening of 1129 Proteins Reveals Novel Urinary Biomarkers of Lupus Nephritis. ACR/ARHP Annual Meeting. Bar Chart Company Logo


 

 

EQUALISE Study in Lupus Nephritis (LN) Study Design Primary Objectives Secondary/Exploratory Objectives Type A Cohort (SLE Patients): Phase 1b N=24 Open-label, dose escalation in patients with active or inactive SLE without LN Type B Cohort (active LN patients): Phase 1b N=32 Randomized, double-blind, placebo controlled in active proliferative LN patients with inadequate response to existing therapies Type A and B Cohorts Assess the safety and tolerability of itolizumabin subjects with SLE with and without active proliferative lupus nephritis Determine optimal subcutaneous dose level(s) of itolizumab Type A and B Cohorts Characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of itolizumab Understand changes in disease serologies, urinary ALCAM and CD6, CD6 receptor occupancy Type B Cohort only Assess the clinical activity of itolizumab (Proteinuria and SLEDAI-2K) Type A Cohort initial data expected 2H2020 Type B Cohort initial data expected 1H 2021 Company Logo


 

 

Corporate


 

 

Corporate Biocon Exclusive rights for the U.S. & Canada and rights to negotiate itolizumab licensing in select ex-North America markets Robust IP portfolio and 12-year Biologics Exclusivity Biocon partnership provides risk-mitigated product supply on attractive terms  CMC completed and itolizumab currently manufactured at commercial scale in FDA-regulated facility Drug product supplied at no cost for 3 concurrent orphan indicationsuntil first U.S. approval; all other clinical supply at cost Robust IP portfolio and 12-year Biologics Exclusivity Strengthened balance sheet and lean operating model expected to fund current development programs into 2H 2021 Pursuing opportunities for strategic pipeline expansion Biologics Exclusivity is subject to significant uncertainty Company Logo


 

 

Summary First in class: Itolizumab is the first antibody targeting the novel CD6/ALCAM pathway for the treatment of severe immune-inflammatory disorders Pipeline in a product: Itolizumab has broad potential disease modifying therapeutic utility Focused Development: Strong scientific rationale and translational validation supporting initial indications in areas of unmet need launching multiple clinical studies during 2019 High value partnership: Biocon partnership provides clinical & commercial product, commercial scale production at FDA regulated facility Accomplished team:Experienced in drug discovery, development and commercialization EQ resources Equillium is capitalized and staffed to deliver on key programs into 2H 2021 Company Logo


 

 

Equillium, Inc.2223 Avenida de la Playa / Suite 105La Jolla, CA 92037www.equilliumbio.comir@equilliumbio.com

eq-ex992_154.htm

EXHIBIT 99.2

 

 

 

Equillium Announces Initiation of the EQUALISE Phase 1b Clinical Trial of Itolizumab for Patients with Lupus Nephritis and Provides Business Update

 

Company secures up to $20 million debt facility with Silicon Valley Bank and Oxford Finance LLC

 

Company receives exclusive rights to negotiate licensing rights to develop and commercialize itolizumab in select major markets outside of North America

 

Management to host conference call today, Tuesday, October 1, at 4:30 p.m. ET

 

 

LA JOLLA, Calif., Oct. 1, 2019Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop products to treat severe autoimmune and inflammatory disorders, today announced it has initiated the EQUALISE Phase 1b clinical trial of itolizumab (EQ001) in patients with lupus nephritis and provided an update on its ongoing clinical programs. Additionally, Equillium announced an agreement with Silicon Valley Bank and Oxford Finance to secure a term loan for up to $20 million, and that the company has secured exclusive rights to negotiate licensing rights with third parties to develop and commercialize itolizumab in select major markets outside of North America.

 

“We are pleased with the progress that we’ve made in a short period of time. We have initiated three clinical trials of itolizumab in lupus nephritis, uncontrolled asthma and acute graft-versus-host disease where there is a substantial need to address the severe aspects of these diseases for patients where there are few to no therapies approved,” said Daniel Bradbury, chairman and chief executive officer of Equillium. “We are optimistic about our trajectory to advance itolizumab for patients in these indications and are proud to partner with Silicon Valley Bank and Oxford Finance to further strengthen our cash position.”

 

EQUALISE is a Phase 1b multiple ascending dose trial that is evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD), and clinical activity of itolizumab in patients with systemic lupus erythematosus (SLE) and lupus nephritis. Data from the SLE cohort of this trial is expected in the second half of 2020, with data from the lupus nephritis cohort expected in the first half of 2021. The trial design and initiation has been a joint effort with the lupus community including working closely with leading clinical and scientific experts in the lupus field, the Lupus Research Alliance, and patients living with lupus and/or lupus nephritis.

 

“The current treatment landscape for patients with lupus nephritis presents limited options with a host of side effects, such as hypertension, diabetes complications, weight gain and predispositions to infections,” said Dr. Ken Kalunian, professor of clinical medicine at the University of California San Diego School of Medicine and the lead principal investigator on the EQUALISE trial. “The EQUALISE trial leverages a novel drug that can broadly target multiple parts of the pathways that lead to disease. Up until now, I’ve only seen medicines that focus on single targets that have produced limited results for patients. Our team looks forward to evaluating itolizumab in the clinic with the hope of filling this significant unmet medical need for lupus nephritis patients.”


 

 

 

"The initiation of the EQUALISE trial is a welcome advance toward testing a potential new treatment for this dangerous and common complication of lupus," noted Lupus Research Alliance president and chief executive officer Kenneth M. Farber. "We commend Equillium for enlisting the lupus community in the development of educational materials about the trial as patients' thorough understanding of the clinical research process is vital to participation."

 

Importantly, the EQUALISE trial is also evaluating urinary biomarkers including soluble ALCAM and CD6 to inform a patient selection approach as part of a companion diagnostic strategy. This approach may help address the heterogeneity of the disease and tackle a key issue that has been a challenging aspect of developing drugs in this field. To advance the diagnostic strategy and assay development, Equillium has partnered with Exagen, a commercial diagnostics company with expertise in diagnosing, prognosing and monitoring lupus patients. Translational data underpinning this strategy as well as preclinical proof of concept data will be presented at the upcoming Annual Meeting of the American College of Rheumatology in November 2019.

 

Equillium today also provided an update on its existing clinical programs in uncontrolled asthma and acute graft-versus-host disease (aGVHD), as well as a general corporate update.

 

Uncontrolled Asthma:

EQUIP is a Phase 1b trial of itolizumab in patients with moderate to severe uncontrolled asthma and is enrolling a broad range of asthma phenotypes including Th2 and non-Th2 driven asthma. The trial was initiated in June 2019 and is being conducted at leading asthma centers in Australia and New Zealand.  A majority of clinical trial sites have been activated and enrollment is progressing as anticipated. The company remains on track to announce topline data in the second half of 2020.

 

Acute Graft-Versus-Host Disease:

EQUATE is a Phase 1b/2 trial of itolizumab in patients with aGVHD. Enrollment in the first part of the study, the Phase 1b portion, has been progressing slower than expected. The reasons for slow enrollment include longer site activation timelines at academic centers, a smaller number of available severe aGVHD patients as defined by the High-Risk MacMillan Criteria, which constitutes a smaller portion of the overall aGVHD population, and higher screen failure rates due to comorbid conditions in this severe aGVHD population.  

 

Physician interest and engagement in this program remains very high, and Equillium continues to activate additional centers to further increase the size of the pool of eligible patients. The company expects that opening these centers will help shift the dynamic of enrollment by allowing Equillium more opportunities to find eligible patients. Further, the company is working with U.S. Food and Drug Administration to re-evaluate the entry criteria into the Phase 1b portion of the trial to further expand the pool of patients eligible for the study. Given the current progress, the company is revising guidance to announce topline data from the Phase 1b portion of this study to the second half of 2020.

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General Corporate Update:

Equillium has partnered with Silicon Valley Bank and Oxford Finance to secure a term loan for up to $20 million in three tranches. On September 30, 2019, the company closed on the first tranche of $10 million. Additional tranches of $5 million each may close within certain timeframes upon achieving sufficient data from the Phase 1b EQUIP trial in uncontrolled asthma and the Phase 1b portion of the EQUATE trial in aGVHD. This financing, together with the company’s existing cash on the balance sheet, is expected to fund currently planned clinical development programs into the second half of 2021 and through the anticipated initial data readouts.  

 

Additionally, in August 2019, the company entered into an agreement with Biocon that grants exclusive rights to Equillium to negotiate licensing rights with third parties to develop and commercialize itolizumab in select major markets outside of North America. This agreement allows Equillium to represent itolizumab more broadly commercially and participate in value that may be created with strategic partners across geographies.  

 

Conference Call and Webcast Information:

Equillium management will be hosting a conference call to provide additional details and discuss upcoming milestones. Call details are as follows:

 

Date: October 1, 2019
Time: 4:30 p.m. ET | 1:30 p.m. PT
Dial-in: (866) 930-5156 (International callers please use (409) 937-8975) and use reservation code: 7080957. Please dial in 5 to 10 minutes prior to scheduled start time.

 

Webcast: www.equilliumbio.com, accessed through the “Investors” section of Equillium's website. The webcast will be archived and available for replay on Equillium’s website for 30 days following the call. Please log on approximately 5 to 10 minutes prior to scheduled start time to download and install any audio software if needed.

 

About Equillium

Equillium is a biotechnology company leveraging deep understanding of immunobiology to develop products to treat severe autoimmune and inflammatory disorders with high unmet medical need.

 

Equillium’s initial product candidate, itolizumab (EQ001), is a clinical-stage, first-in-class monoclonal antibody that selectively targets the novel immune checkpoint receptor CD6. CD6 plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Itolizumab is a clinically-validated therapeutic that has demonstrated a favorable safety and tolerability profile. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited. Equillium believes that itolizumab has the potential to be a best-in-class disease modifying therapeutic and is advancing itolizumab into clinical development in multiple immuno-inflammatory indications with high unmet medical need.  For more information, visit www.equilliumbio.com.

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Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Equillium’s plans and expected timing for developing itolizumab, including the expected timing of clinical trial results, the potential benefits of itolizumab and cash runway. Risks that contribute to the uncertain nature of the forward-looking statements include uncertainties related to the completion of clinical trials, whether the results from clinical trials will validate and support the safety and efficacy of itolizumab and having to use cash in ways or on timing other than expected. These and other risks and uncertainties are described more fully under the caption "Risk Factors" and elsewhere in Equillium's filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Equillium undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

 

Investor Contact

+1-858-412-5302

ir@equilliumbio.com

 

Media Contact

Cammy Duong

Canale Communications

+1-619-849-5389

cammy@canalecomm.com

 

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